BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIATAIN ALGINATE AG

    MDR report key: 11937412 · Received June 4, 2021

    Report

    Report Number
    8044178-2021-00002
    Event Type
    Injury
    Date Received
    June 4, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 4, 2021
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS LTD
    Product Code
    FRO
    PMA / PMN Number
    K090453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT WAS RECEIVED THAT A PATIENT HAD BEEN USING BIATAIN ALGINATE FOR THREE MONTHS AND HAD EXPERIENCED A NUMBER OF SYMPTOMS INCLUDING EXTREME PAIN AT THE BACK OF HER HEAD, PAIN AT THE BACK OF HER EYES, DEEP ROOTED PAIN IN HER SPINE AND HAD NOTICED A SILVER DISCOLORATION AROUND THE WOUND SITE. THE PATIENT ADVISED THAT SHE HAD USED OVER 100 DRESSINGS, SOMETIMES CHANGING THEM TWICE A DAY. THE IFU INDICATES THAT THE PRODUCT IS INTENDED FOR SHORT TERM USE FOR UP TO 30 DAYS AND IT IS HIGHLY LIKELY THAT THE PATIENT DID NOT HEED THIS PRECAUTION AND USED THE PRODUCT FOR A MUCH LONGER PERIOD. WE HAVE NO FURTHER INFORMATION AS TO WHETHER THE PATIENT HAS FULLY RECOVERED AND WE WOULD RE-INVESTIGATE THE COMPLAINT SHOULD ADDITIONAL INFORMATION BE PROVIDED. A SERIOUS INJURY DID OCCUR, ALTHOUGH THE SYMPTOMS THE PATIENT EXPERIENCED ARE NOT LIFE-THREATENING, THEY DID RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION AND MAY REQUIRE INTERVENTION TO PREVENT FURTHER IMPAIRMENT IN THE FORM OF ARGYRIA SO THEREFORE THIS COMPLAINT IS REPORTABLE. THE RISK OF SERIOUS HARM FROM LOW DOSES OF SILVER, GIVEN OVER A SHORT TERM, IS SMALL. CHRONIC INGESTION OF SILVER PREPARATIONS CAN LEAD TO ARGYRIA IN THE SKIN AND OTHER ORGANS. THIS IS NOT LIFE-THREATENING, BUT IS CONSIDERED BY MOST TO BE COSMETICALLY UNDESIRABLE.

    Description of Event or Problem · 1

    PATIENT WAS USING BIATAIN ALGINATE AG FOR AN EXTENDED PERIOD OF TIME FOR A LEFT LEG LATERAL ULCER. ACCORDING TO THE PATIENT SHE HAS USED A TOTAL OF AROUND 100 DRESSINGS, OFTEN CHANGING THEM ONCE OR TWICE A DAY. SHE DISCONTINUED ITS USE EARLY APRIL AND HAS BEEN EXPERIENCING THE FOLLOWING SYMPTOMS: EXTREME PAIN AT THE BACK OF HER HEAD. PAIN AT THE BACK OF HER EYES. DEEP ROOTED PAIN IN HER SPINE. DESPITE DISCONTINUATION OF THE PLASTERS, UPON WAKING SHE OBSERVES A SILVER PATTERN DISCOLORATION AROUND. THE WOUND SITE. IT APPEARS LIKELY THAT THE PATIENT HAS SOME FORM OF ARGYRIA AT THE WOUND SITE - IT IS UNCLEAR IF THE PAIN FELT IS AS A RESULT OF THIS, IS CAUSED BY THE DRESSING OR BY ANOTHER UNKNOWN FACTOR OR COMORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833283 BIATAIN ALGINATE AG SILVER ALGINATE II (14-24AP) FRO ADVANCED MEDICAL SOLUTIONS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R